locally advanced pancreatic carcinoma synonyme: inoperable pancreatic cancer without metastases
Conditions
Interventions
Criteria for LAPC are based on the guidelines of the National Comprehensive
Cancer Network. For each individual patient, these criteria will be judged in
consensus by a multidisciplinary hepatobilia
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Screening must be performed no longer than 2 weeks prior to study inclusion. Subjects are eligible if they meet the following criteria:;* Histologic or cytologic confirmation of primary pancreatic carcinoma; * Radiologic confirmation of unresectable pancreatic carcinoma without distant metastases by at least ceCT of chest and abdomen, performed maximum 2 weeks prior to the procedure; * Maximum tumor diameter * 5 cm; * Age * 18 years; * ASA-classificaton 0 * 3; * Life expectancy of at least 12 weeks; * Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to definite inclusion; - Hemoglobin * 5.6 mmol/L; - Absolute neutrophil count (ANC) * 1,500/mm3; - Platelet count * 100*109/l; - Total bilirubine * 1.5 times the upper limit of normal (ULN); - ALT and AST * 2.5 x ULN; - Serum creatinine * 1.5 x ULN or a calculated creatinine clearance * 50 ml/min; - Prothrombin time or INR
Exclusion criteria
Exclusion criteria: Subjects who meet the following criteria at the time of screening will be excluded: * Resectable pancreatic adenocarcinoma as discussed by our multidisciplinary hepatobiliary team; * Extrapancreatic metastases; * Successful downstaging after (radio)chemotherapy from previous unresectable/borderline tumor to resectable tumor; * History of epilepsy; * History of cardiac disease: - Congestive heart failure >NYHA class 2; - Active Coronary Artery Disease (defined as myocardial infarction within 6 months prior to screening); - Ventricular cardiac arrhythmias requiring anti-arrhythmic therapy or pacemaker (beta blockers for antihypertensive regimen are permitted); * Uncontrolled hypertension. Blood pressure must be *160/95 mmHg at the time of screening on a stable antihypertensive regimen; * Compromised liver function (e.g. signs of portal hypertension, INR > 1,5 without use of anticoagulants, ascites); * Uncontrolled infections (> grade 2 NCI-CTC version 3.0); * Pregnant or breast-feeding subjects. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment; * Immunotherapy * 6 weeks prior to the procedure; * Chemotherapy * 6 weeks prior to the procedure; * Radiotherapy * 6 weeks prior to the procedure; * Concomitant use of anti-convulsive and anti-arrhythmic drugs (other than beta blockers for hypertension); * Allergy to contrast media; * Any implanted stimulation device; * Any condition that is unstable or that could jeopardize the safety of the subject and their compliance in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome of the study is the safety of IRE for the treatment of locally advanced pancreatic carcinoma, By registration and analysis of adverse events and serious adverse events, incidence and severity of complications within 90 days after the intervention are investigated and morbidity and mortality will be determined. Late complications that might be related to the intervention (listed in the study protocol under paragraph 12.1), will always be registered and reported if necessary (in case of SAE's). These results will be compared to patients that have undergone radio- and or chemotherapy alone. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary parameters are (see paragraph 2.1.2. from the project protocol): - Feasibility: parameters are willingness of patients to participate, number of eligible patients, total procedure time, ablation time, number of tme of replacement of the electrodes (expressed in learning curve) -Efficacy, as expressed in: 1. Symptomatic response: Quality of life, pain registration and pain medication and general performance status 2. Tumor evaluation: Size and shape of the ablation area, ablation success and local recurrence rate (by CT and MRI) - Immunologic response: by investigating the T-cell specific immune reaction, before, 2 weeks and 3 months after IRE. - Exocrine pancreatic function, smaal bowel absorption capacity and body fat composition | — |
Countries
Netherlands
Outcome results
None listed